Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687934
• Other study ID #: 9090-02
• Secondary ID: 9090-02
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2008
• Last updated: September 17, 2014
• Start date: October 2007
• Est. completion date: October 2011

Study information

• Verified date: September 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• Patients must be documented to be refractory or not candidates for current approved therapies.

• Must have an ECOG status 0-2.

• Peripheral neuropathy < or = 2.

• Must have acceptable organ and marrow function per protocol parameters.

• No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria:

• Must not be pregnant or breastfeeding.

• Chemotherapy or radiation within 3 weeks.

• Previous radiation to >25% of total bone marrow.

• Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.

• Primary brain tumors or active brain metastases.

• Use of any investigational agents within 4 weeks.

• Treatment with chronic immunosuppressants.

• Uncontrolled, intercurrent illness.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• STA-9090
This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Locations

Country	Name	City	State
United States	US Oncology Dayton Oncology and Hematology, P.A	Kettering	Ohio
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities		Cycle 1	Yes